Study to Investigate the Safety and Duration of Effect of Different Botulinum Toxin A (NT 201) Dose Groups Following the Treatment of Glabellar Frown Lines
- Registration Number
- NCT03806933
- Lead Sponsor
- Merz Aesthetics GmbH
- Brief Summary
The purpose of the study is to investigate the safety and duration of effect following different doses of Botulinum Toxin A (NT 201) in the treatment of glabellar frown lines (GFL).
- Detailed Description
This prospective, randomized, double-blind, multi-Center clinical study consists of a two stage experimental main period comparing different dose groups, followed by an optional open-label extension period (20 Units follow-up treatment).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 241
- Male or female participant 18 years or over.
- Moderate (score=2) to severe (score=3) GFL at maximum frown as assessed by investigator on the 4-point facial wrinkle scale (FWS).
- Moderate (score=2) to severe (score=3) GFL at maximum frown as assessed by participant on the 4-point FWS.
- Previous treatment with Botulinum neurotoxin (BoNT) of any serotype in the facial area within the last 12 months before injection.
- Previous treatment with any facial cosmetic procedure (example, chemical peeling, photo rejuvenation, mesotherapy, photodynamic therapy, laser treatment, tattooing of eyebrows) in the glabellar area within the last 12 months before injection.
- Previous treatment with any biodegradable filler in the glabellar area within the last 12 months before injection.
- Inability to substantially reduce GFL by physically spreading them apart as assessed by the investigator.
- Excessively thick sebaceous skin or hypertrophic muscles in the upper third part of the face.
- Any surgery or scars in the glabellar area.
- Marked facial asymmetry.
- Eyelid ptosis.
- Marked brow ptosis and/or dermatochalasis.
- Ongoing severe or unstable medical conditions, example, systemic infection, or pulmonary disease, at the discretion of the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NT 201 Dose group 1 NT 201 Stage 1 and 2. Intramuscular injection into the glabellar area. NT 201 Dose group 2 NT 201 Stage 1. Intramuscular injection into the glabellar area. NT 201 Dose group 4 NT 201 Stage 2. Intramuscular injection into the glabellar area. NT 201 Dose group 3 NT 201 Stage 1. Intramuscular injection into the glabellar area. NT 201 Dose group 5 NT 201 Open Label Extension Period. Intramuscular injection into the glabellar area.
- Primary Outcome Measures
Name Time Method Number of Participants With at Least One Treatment-emergent Serious Adverse Event (TESAE) From the time of first treatment up to Day 390 Number of Participants With at Least One Treatment Related TEAE From the time of first treatment up to Day 390 Number of Participants With at Least One Treatment-emergent Adverse Event of Special Interest (TEAESI) From the time of first treatment up to Day 390 Number of Participants With at Least One Treatment Related TESAE From the time of first treatment up to Day 390 Duration of Effect Defined as Time Between Treatment and Relapse to Baseline Status Assessed by the Investigator on the FWS From the time of first treatment up to Day 360 Duration of effect: time between treatment and first occurrence of relapse to baseline status. If no effect was observed, duration of effect was set to 0. Effect: any improvement (at least 1 point) at maximum frown as assessed by investigator on FWS. Investigator's FWS assessed status of GFL according to 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \[that is, visible furrows\]), 2 (moderately strong muscle action possible \[that is, visible muscle bulges\]), 3 (strong muscle action possible which may cause local pallor). Duration of effect was analyzed using Kaplan-meier analysis, and 95 percent (%) confidence interval (CI) were calculated using log-log transformation.
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) From the time of first treatment up to Day 390
- Secondary Outcome Measures
Name Time Method Percentage of Participants Rated as None (0) or Mild (1) at Maximum Frown by Participant's Rating on FWS At Day 180 Participant's FWS assessed status of GFL according to the 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for participant's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \[that is, visible furrows\]), 2 (moderately strong muscle action possible \[that is, visible muscle bulges\]), 3 (strong muscle action possible which may cause local pallor). 95% CI for percentage of participants were based on Pearson-clopper method.
Percentage of Participants Rated as at Least 1-point Improvement Compared to Baseline at Maximum Frown by Investigator's Rating on FWS At Day 180 Investigator's FWS assessed status of GFL according to the 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \[that is, visible furrows\]), 2 (moderately strong muscle action possible \[that is, visible muscle bulges\]), 3 (strong muscle action possible which may cause local pallor). 95% CI for percentage of participants were based on Pearson-clopper method.
Duration of Effect Whereby Effect Was Defined as Score of None (0) or Mild (1) at Maximum Frown as Assessed by the Investigator According to FWS From the time of first treatment up to Day 360 Duration of effect was defined as time between treatment and first point in time when score was moderate or severe again. If no effect was observed, duration of effect was set to 0. Effect was defined by a score of none (0) or mild (1) at maximum frown as assessed by investigator according to FWS. Investigator's FWS assessed status of GFL according to 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \[that is, visible furrows\]), 2 (moderately strong muscle action possible \[that is, visible muscle bulges\]), 3 (strong muscle action possible which may cause local pallor). Duration of effect was analyzed using Kaplan-meier analysis, and 95% CI were calculated using log-log transformation.
Duration of Effect Whereby Effect Was Defined by 2-point Improvement From Baseline at Maximum Frown as Assessed by the Investigator According to FWS From the time of first treatment up to Day 360 Duration of effect: time between treatment and first point in time when improvement was less than 2 points again. If no effect was observed, duration of effect was set to 0. Effect: at least a 2-point improvement from baseline at maximum frown as assessed by investigator on the FWS. Investigator's FWS assessed status of GFL according to 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \[that is, visible furrows\]), 2 (moderately strong muscle action possible \[that is, visible muscle bulges\]), 3 (strong muscle action possible which may cause local pallor). Duration of effect was analyzed using Kaplan-meier analysis, and 95% CI were calculated using log-log transformation.
Percentage of Participants Rated as None (0) or Mild (1) at Maximum Frown by Investigator's Rating on FWS At Day 180 Investigator's FWS assessed status of GFL according to the 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \[that is, visible furrows\]), 2 (moderately strong muscle action possible \[that is, visible muscle bulges\]), 3 (strong muscle action possible which may cause local pallor). 95% CIs for percentage of participants were based on Pearson-clopper method.
Percentage of Participants Rated as at Least 1-point Improvement Compared to Baseline at Maximum Frown by Participant's Rating on FWS At Day 180 Participant's FWS assessed status of GFL according to the 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for participant's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \[that is, visible furrows\]), 2 (moderately strong muscle action possible \[that is, visible muscle bulges\]), 3 (strong muscle action possible which may cause local pallor). 95% CI for percentage of participants were based on Pearson-clopper method.
Trial Locations
- Locations (9)
Medical Associates Inc., Merz Investigational Site #0010435
🇺🇸Newport Beach, California, United States
Skin & Laser Center, Merz Investigational Site #0490362
🇩🇪Potsdam, Germany
Clinical Testing of Beverly Hills, Merz Investigational Site #0010395
🇺🇸Encino, California, United States
The Maas Clinics, Merz Investigational Site #0010338
🇺🇸San Francisco, California, United States
Tennessee Clinical Research Center, Merz Investigational Site #0010097
🇺🇸Nashville, Tennessee, United States
Dermatologische Gemeinschaftspraxis Dr. Prager und Partner, Merz Investigational Site #0490345
🇩🇪Hamburg, Germany
Universität Hamburg, Fachrichtung Kosmetik und Körperpflege, Merz Investigational Site #0490095
🇩🇪Hamburg, Germany
Cosmetic Laser Dermatology, Merz Investigational Site #0010321
🇺🇸San Diego, California, United States
Privatpraxis für Dermatologie und Ästhetische Medizin, Merz Investigational Site #0490306
🇩🇪Berlin, Germany